MT-6402 for Solid Cancers

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Molecular Templates, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This will be a Phase 1 Open-label, dose escalation and expansion study of MT-6402 (an Engineered Toxin Body (ETB)) in subjects with advanced solid cancer that expresses PD-L1

Eligibility Criteria

Adults with advanced solid cancers expressing PD-L1, who have measurable disease and are not suitable for standard treatments or have refused them. They must be in relatively good health (ECOG score of 0 or 1), have adequate organ function, and if they've had cancer immunotherapy, it should include a CPI. Women must test negative for pregnancy and all participants agree to contraception.

Inclusion Criteria

I have taken a pregnancy test within the last 3 days and it was negative.

My kidneys work well, with a creatinine clearance rate of 50 mL/min or higher.

My disease can be measured or seen on tests.

I have been treated with immune checkpoint inhibitors for my cancer.

My liver functions are within the required range for the trial.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have lasting side effects from previous immunotherapy.

I have severe lung inflammation not caused by an infection.

I am not pregnant or breastfeeding.

I have an autoimmune disease that hasn't needed treatment in the last 2 years.

I have or had another type of cancer.

I have received a transplant from a donor.

I have a history of serious heart problems.

I am not receiving any cancer treatment except for palliative care on specific areas.

I don't have tissue from my cancer that has spread, or I can't or won't consent to a biopsy.

I am taking more than 10 mg/day of steroids.

Participant Groups

MT-6402 is being tested in this Phase 1 trial. It's an Engineered Toxin Body (ETB) aimed at treating patients whose solid tumors express the protein PD-L1. The study involves escalating doses to determine safety and effectiveness, followed by expansion to further assess these parameters.

4Treatment groups

Experimental Treatment

Group I: PD-L1 positive advanced cancerExperimental Treatment1 Intervention

Subjects with PD-L1 positive advanced cancer (solid tumors)

Group II: PD-L1 Positive SCCHNExperimental Treatment1 Intervention

Subjects with PD-L1 Positive Squamous Cell Carcinoma of the head and neck (SCCHN), refractory to or ineligible for platinum-based therapy, who received prior PD-1/PD-L1 treatment

Group III: PD-L1 Positive NSCLCExperimental Treatment1 Intervention

Subjects with PD-L1 Positive Lung Carcinoma (NSCLC) who received prior PD-1/PD-L1 treatment

Group IV: Other relapsed/refractory PD-L1 positive solid tumorsExperimental Treatment1 Intervention

Subjects with any other relapsed or refractory PD-L1 positive solid tumor who received PD-1/PD-L1 treatment.